RE:RE:RE:RE:RE:RE:RE:RE:ANTIGEN TESTS SEEKING HC APPROVALYes, we have. What MRIGlobal produced was NOT A CLINICAL STUDY, no matter how many times you insist it was. These are laboratory studies, nothing more. If you don't believe me, read FIND's protocol summary which clearly explains the difference here: https://www.finddx.org/wp-content/uploads/2020/04/20200421-COVID-Ag-RDT-Evaluation-Synopsis.pdf
The primary objectives state:
1.1[Lab Evaluation] To determine the relative analytical sensitivity of COVID-19 antigen RDTs (index test) using contrived specimens: respiratory swab samples spiked with known quantities of cultured viral isolate.
1.2[Clinical Evaluation] To determine the diagnostic accuracy of COVID-19 antigen RDTs in patients presenting with influenza-like illness using upper respiratory tract specimens compared to gold-standard RT-PCR.
MRIGlobal performed a lab evaluation, which everyone seems to be relying on as '3rd party validation'. The only clinical data Sona has declared is the Saudi study. FIND would offer a route to validate this data clinically, hence my hope this happens.
Anyway, it's pointless arguing about this because you do not seem to understand this most fundamental concept of developing a diagnostic. GLTA